Evidence map›Paper›PMID 26931101›Full record

ArticleHealth and quality of life outcomes2016

Estimation of minimal clinically important change of the Japanese version of EQ-5D in patients with chronic noncancer pain: a retrospective research using real-world data.

Kazutake Yoshizawa, Hisanori Kobayashi, Motoko Fujie, Yoshimasa Ogawa, Tsutomu Yajima, Koji Kawai

Abstract read
In one paragraph

Article in Health and quality of life outcomes, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. A systematic review of minimum important changes for generic multi-attribute utility instruments and recommendations for their estimation.The European journal of health economics : HEPAC : health economics in prevention and care · 2025
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Observational
  6. Minimum clinically important change for outcome scores among patients aged 75 or over undergoing lumbar spine surgery.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2021
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Kazutake YoshizawaMedical Affairs Division, Janssen Pharmaceutical K.K., 3-5-2, Nishikanda, Chiyoda-ku, Tokyo, Japan. kyoshiz1@its.jnj.com.
Hisanori KobayashiMedical Affairs Division, Janssen Pharmaceutical K.K., 3-5-2, Nishikanda, Chiyoda-ku, Tokyo, Japan. hkobaya1@its.jnj.com.
Motoko FujieJapan Safety & Surveillance Division, Janssen Pharmaceutical K.K., 3-5-2, Nishikanda, Chiyoda-ku, Tokyo, Japan. mfujie@its.jnj.com.
Yoshimasa OgawaJapan Safety & Surveillance Division, Janssen Pharmaceutical K.K., 3-5-2, Nishikanda, Chiyoda-ku, Tokyo, Japan. yogawa2@its.jnj.com.
Tsutomu YajimaBiostatistics Department, Quantitative Science Division, Janssen Pharmaceutical K.K., 3-5-2, Nishikanda, Chiyoda-ku, Tokyo, Japan. tyajima1@its.jnj.com.
Koji KawaiMedical Affairs Division, Janssen Pharmaceutical K.K., 3-5-2, Nishikanda, Chiyoda-ku, Tokyo, Japan. kojikawai2@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQuality of life (QoL) is routinely assessed and evaluated in medical research. However, in Japan, there is a lack of solid cutoff criteria for evaluating QoL improvement in chronic noncancer pain management. The present study was conducted to identify the minimal clinically important change (MCIC) of the Japanese version of EuroQol-5D 3L(EQ-5D) utility score and numeric rating scale (NRS) with an emphasis on chronic noncancer pain.

methodsThe data source for this post hoc research was the post-marketing surveillance (PMS) data for a tramadol/acetaminophen combination tablet, which was previously conducted in real-world settings. The parameters extracted from the PMS data were sociodemographic characteristics, NRS, EQ-5D, and dichotomous physician's global impression of treatment effectiveness (PGI). The optimal cutoff points of MCIC for EQ-5D utility and NRS scores were evaluated using receiver operating characteristics (ROC) analysis. An anchor-based approach using PGI was applied.

resultsData of 710 patients with chronic noncancer pain were extracted from the PMS database. The NRS score decreased by 2.7 (standard deviation, 2.3) points, whereas the EQ-5D score increased by 0.16 (0.20) points at 4 weeks from baseline. The changes from baseline in NRS and EQ-5D were significantly correlated (r = 0.53, p < 0.001). The estimated optimal cutoff points of MCIC for EQ-5D and NRS were 0.10 and -2.0 points, respectively. The area under the curve of ROC was > 0.80 in both analyses.

conclusionThese results demonstrated novel cutoff criteria for the Japanese version of EQ-5D, focusing on patients with chronic noncancer pain. The obtained criteria were fairly consistent and can be confidently utilized as an evaluation tool in medical research on chronic noncancer pain in Japan, with additional functionality and usability for QoL assessment in pain management practice.

trial registrationThe data source of this post hoc research was a PMS study with the identifier number UMIN000015901 at umin.ac.jp, UMIN clinical trial registry (UMIN-CTR).

Indexed as

AdultAgedAged, 80 and overAnalgesics, OpioidChronic PainFemaleHumansJapanMaleMiddle AgedPatientsQuality of LifeRegression AnalysisRetrospective StudiesTramadolTreatment OutcomeAnalgesics, OpioidTramadol

Identifiers

PMID26931101
PMCPMC4773997

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.